Contact Lens & Anterior Eye 36 (2013) 253258

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Contact Lens & Anterior Eye

journal homepage: www.elsevier.com/locate/clae

Geographic and temporal risk factors for interruptions to soft contact

lens wear in young wearers
Kathryn Richdale a, , Dawn Y. Lam b , G. Lynn Mitchell c , Robin L. Chalmers d ,
Meredith E. Jansen e , Beth T. Kinoshita f , Luigina Sorbara g , Heidi Wagner h
a
State University of New York College of Optometry, New York, New York, United States
b
Southern California College of Optometry, Fullerton, California, United States
c
Ohio State University College of Optometry, Columbus, Ohio, United States
d
Clinical Trials Consultant, Atlanta, GA, United States
e
Indiana University School of Optometry, Bloomington, Indiana, United States
f
Pacic University College of Optometry, Forest Grove, Oregon, United States
g
University of Waterloo School of Optometry and Vision Science, Waterloo, Ontario, Canada
h
Nova Southeastern University College of Optometry, Fort Lauderdale, Florida, United States

a r t i c l e i n f o a b s t r a c t

Article history: Objectives: This was a secondary analysis of an existing dataset of soft contact lens wearers age 833
Received 27 November 2012 years, who received eye care outside of a clinical trial. The aim was to identify geographical and temporal
Received in revised form 16 January 2013 factors associated with interruptions to contact lens wear.
Accepted 7 February 2013
Methods: Data from six academic centers in North America captured 522 events in 3549 patients. Cases
were analyzed overall and in subcategories of allergic, and serious and signicant adverse events. General
Keywords:
estimating equations were used to model the effect of geographic (Northwest, West, Central, Northeast,
Soft contact lenses
Southeast) and temporal (season, month, day of the week) factors, along with previously identied risk
Complications
Season factors associated with interruptions in lens wear (patient age, contact lens material, overnight wear,
Region lens care system, replacement schedule, and years of contact lens wear).
Corneal inammatory events Results: After controlling for established risk factors, both region and temporal factors disrupted the
patients ability to maintain contact lens wear. About 4% of all visits had complications that led to an
interruption in wear. Allergic events were highest in the Central region. Serious and signicant adverse
events peaked in the Southeast during the Autumn and Winter months (September, October, December).
Day of the week was not signicant in any model.
Conclusions: This study provides evidence of seasonal and regional challenges to contact lens wear. As the
use of soft contact lenses expands for both cosmetic and medical reasons, practitioners must examine
ways to maintain continuous, safe, and healthy use of contact lenses across all patients.
Published by Elsevier Ltd on behalf of British Contact Lens Association.

1. Introduction
Clinicians and researchers have studied factors that drive soft
contact lens complications since the commercial availability of soft
contact lenses. To date, most research has focused on serious and
signicant events which have the potential to cause permanent
vision loss, specically corneal inammatory events and micro-
bial keratitis [13]. Multiple risk factors for these events have been
identied including patient age, smoking status, sleeping in contact
lenses and the use of certain classes of contact lens materials and
lens care products [14].
Corresponding author at: State University of New York College of Optometry,
33 West 42nd Street, New York, NY 10036, United States. Tel.: +1 212 938 4165.
E-mail address: KRichdale@SUNYopt.edu (K. Richdale).
Soft contact lens use for both cosmetic and medical purposes
(myopia control, drug delivery, glucose monitoring, etc.) is on the
rise and will extend the use of soft contact lenses to more and varied
patients [59]. Thus, there is a growing need to understand the risks
for not just serious and signicant events, but for any disruption to
healthy contact lens wear, as any of these events could interfere
with the planned delivery of optical treatments or monitoring of
medical conditions.
While randomized controlled clinical trials are the gold standard
for studying interventions, they can introduce bias in the study of
contact lens behaviors, as contact lenses and lens care products
are often provided to the patient free of charge. These patients
are carefully screened, instructed, and monitored for good con-
tact lens wear and care practices. The Contact Lens Assessment
in Youth (CLAY) Group conducted a retrospective chart review of
pediatric and adult soft contact lens wearers examined in routine

1367-0484/$ see front matter. Published by Elsevier Ltd on behalf of British Contact Lens Association.
http://dx.doi.org/10.1016/j.clae.2013.02.002
254 K. Richdale et al. / Contact Lens & Anterior Eye 36 (2013) 253258
practice at six academic centers in North America. The primary
aim of that study was to examine age and other patient- and
contact-lens-related-factors associated with interruptions to cos-
metic (non-medical) contact lens wear. The results of that study
have been published and reported age between 15 and 25 years,
greater than one year of contact lens experience, reusable contact
lens replacement schedule, multipurpose lens care products, and
silicone hydrogel contact lens material were related to interrup-
tions in contact lens wear [10].
Clinical experience and industry reports on therapeutic pre-
scribing patterns have suggested that there may be geographic and
temporal variations in some contact lens complications [1114].
There is a scarcity of recent objective evidence to support the exis-
tence of differing complications by region or season. Knowledge of
regional or temporal risk factors could guide practitioners to min-
imize these events through the choice of different lenses or lens
care, or at the very least, to plan for a potential rise in events. With
this in mind, a secondary analysis was conducted using data from
the CLAY retrospective study to determine if geographic region,
season, month of the year, or day of the week were associated with
interruptions to soft contact lens wear in that population.
2. Methods
Detailed methods of the retrospective chart review conducted
by the CLAY study group have been described previously and
are summarized here [15]. After approval by Institutional Review
Boards at each academic center, eye care records of 3549 soft con-
tact lens wearers were reviewed for 14,305 visits observing 4663
SCL years of wear. Criteria for inclusion in the original dataset
were: 833 years of age and a current soft contact lens wearer
with contact lens powers between +8.00 and 12.00 D in either
meridian. Patients using contact lenses for medical reasons (corneal
degeneration or dystrophy, high ametropia) were excluded. Data
were compiled from eye care visits between 2005 and 2009 and
included: age, gender, race, ethnicity, years of contact lens wear,
systemic health (diabetes, autoimmune, allergies), smoking status,
anterior segment slit-lamp ndings, and contact lens and lens care
information (lens brand and power, lens care system, replacement
schedule, overnight wear).
The CLAY group pre-dened soft contact lens related events
as anything that disrupted soft contact lens wear for at least one
day, either by patient self-management, or by doctor recommen-
dation. A complete list of events has been published elsewhere, but
generally included any inammatory, infectious, viral, mechanical
or allergic condition of the cornea, conjunctiva or lids [10]. Events
were later subcategorized as allergic and serious and signicant
adverse events (Table 1). Serious and signicant events were
based on guidelines from the United States (US) Food and Drug
Administration (FDA) and the Cornea and Contact Lens Research
Unit [16,17]. As the number of individual cases for many of the
other diagnoses were low, the only other analysis conducted was
for all events that interrupted soft contact lens wear (combining
allergic, serious and signicant and other categories).
The purpose of this analysis was to examine regional and
temporal factors related to soft contact lens wear interruptions.
Five of the six sites were located in the United States (US), so
geographic regions were classied according to the US National
Oceanic and Atmospheric Administration (NOAA) (Fig. 1) [18]. The
only Canadian site, Waterloo, Ontario is in the humid continen-
tal climate zone, similar to that in the US Northeast [19]. Based
on this, regions were dened as Northwest: Pacic University,
Forest Grove, Oregon; West: Southern California College of Optom-
etry, Fullerton, California; Central: Ohio State University College
of Optometry, Columbus Ohio and Indiana University College of
Table 1
All events included in the current analysis (n = 522). Descriptions and percent of
allergic, serious and signicant adverse events, and other events are indicated.
Classication Total (%)
Allergic events
Allergic conjunctivitis, contact lens induced papillary conjunctivitis 94 (18)
(CLPC), Giant papillary conjunctivitis (GPC), Phlyctenulosis
Serious and signicant adverse events
Bacterial conjunctivitis, Contact lens associated red eye (CLARE) 249 (48)
with or without inltrates, Contact lens peripheral ulcer (CLPU),
Herpes simplex keratitis, Inltrative keratitis, Iritis, microbial
keratitis (MK), viral conjunctivitis or keratoconjunctivitis
Other events
Blepharitis, Contact dermatitis, Chalazion, Hordeolum, Lid 179 (34)
inammation, Trichiasis, Abrasion, Injection, Subconjunctival
hemorrhage, Episcleritis, Toxic conjunctivitis, Corneal abrasion,
Corneal laceration, Corneal staining, Microcystic edema,
Superior epithelial arcuate lesion (SEAL), Superior limbic
keratitis (SLK), Thygesons supercial punctate keratitits (SPK),
Contact lens intolerance, Foreign body, Lice, Symptoms without
signs, Dry eye
Optometry, Bloomington, Indiana; Northeast: Waterloo School of
Optometry and Vision Science, Waterloo, Ontario; Southeast: Nova
Southeastern University College of Optometry, Fort Lauderdale,
Florida. The State University of New York College of Optometry was
not a clinical site at the time of data collection.
The start of each season was dened by the Farmers Almanac as:
March 20: Spring; June 21: Summer; September 22: Autumn; and
December 21 Winter regardless of region [20]. The average tem-
perature in each region and season over the years of observation
(20052009) are presented in Fig. 2 and are consistent with his-
torical and current data [18]. While variation over the ve years of
observation is small, large differences across seasons and regions
can be observed.
For analysis of events by day of the week, Saturday and Sunday
were combined as weekend due to the low visit rate on Sundays.
Events were categorized by the day the patient presented for a visit,
which may or may not have been the day when symptoms rst
began.
Generalized estimating equations were used to describe the
impact of regional and temporal factors on interruptions to soft
contact lens wear. Previously described risk factors identied in the
primary analyses were included in the nal multivariate analysis:
patient age, years of contact lens wear experience, lens material
(hydrogel versus silicone hydrogel), replacement schedule, lens
Fig. 1. Site locations and regions as classied by the United States National Oceanic
and Atmospheric Administration (US NOAA). The only Canadian site (Waterloo,
Ontario) is similar in climate to that of the US Northeast.
 K. Richdale et al. / Contact Lens & Anterior Eye 36 (2013) 253258 255

Fig. 2. Average temperature by region and season from 2005 to 2009 (mean and
standard deviation).

care system and history of overnight wear [4,10]. Regional and tem-
poral factors signicant to the 0.05 level in the univariate models
were included in the multivariate models. Analysis was done using
SAS (Version 9.2, Cary, NC).

3. Results

After exclusion of 34 people who had only one visit and did
not present for their rst visit wearing a contact lens, 3515 con-
tact lens wearers were available for analysis. Data from 12,582
non-event visits and 522 event visits were used for this analysis
(excluded visits: n = 755 visits with no chance of event at visit as
they were new contact lens tting visits and n = 466 visits which
were progress evaluations were excluded from the total number
of visits). The average age of these wearers was 22.0 6.1 years,
63.2% were female, and 49.2% were Caucasian. A complete descrip-
tion of the population has been published elsewhere [10,15]. In this
population, the proportion of visits associated with an event that
interrupted contact lens wear was 3.98%, and allergic and infec-
tious and/or inammatory events comprised about 0.7% and 1.9%
of visits, respectively.
Examining all contact lens interrupting events, region, season
and month were signicant in the univariate analysis (p < 0.05), but
day of the week was not (p = 0.64). In the multivariate model, both
region and season were retained, along with patient age, contact
lens material, years of contact lens wear and replacement sched-
ule (Table 2). There was no interaction between region and season
(p = 0.21). There was a small but signicant increased risk of having
a contact lens interrupting event in any region except Central as
compared to the Northeast (Fig. 3 and Table 2). The highest rate of
Fig. 3. Events by region (top: all events, middle: allergic events, bottom: serious
any contact lens interrupting event occurred in Autumn (Fig. 4).
and signicant adverse events).
For allergic events (n = 94), region was signicant in the uni-
variate model (p < 0.0001) while season (p = 0.09), month (p = 0.34)
and day of the week (p = 0.38) were not. In the full model, region
remained a signicant factor, along with patient age and history there was a visible peak in serious and signicant adverse events
of overnight wear (Table 2). Due to the limited number of allergic in Autumn, the difference was not statistically signicant (Fig. 4).
cases, it was not possible to test for a region by season interaction. Examining the distribution of serious and signicant adverse events
Allergic events were 15 times more likely to occur in the Central by month explains the lack of seasonal signicance since the high-
region, and three to ve times more likely in the Southeast, West est rates occurred during the months of September, October and
or Northwest as compared to the Northeast (Table 2 and Fig. 4). December; straddling seasons dened by the Farmers Almanac
Finally, exploring serious and signicant adverse events, only (Fig. 5).
region (p < 0.001) and month (p = 0.028) were signicant factors in
the univariate models (season, p = 0.18; day of the week, p = 0.75), 4. Discussion
and both were retained in the full analysis with other established
risk factors of age, years of wear, overnight wear and lens care Allergy-associated contact lens complications have been shown
system (Table 2). Following the trend for all events, serious and sig- to occur in Summer, Spring, and Autumn, depending on the region
nicant adverse events were lowest in the Northeast region, with and allergens examined [11,12,21,22]. Seasonal and regional vari-
all other regions being similar at about 2% of visits (Fig. 3). Although ations are also known to exist in other allergy-related disciplines
256 K. Richdale et al. / Contact Lens & Anterior Eye 36 (2013) 253258

Table 2
Multivariate models of soft contact lens interrupting events.

Factor (referent) Level Contact lens interrupting events

All (n = 522) Allergic (n = 94) Serious and signicant (n = 249)

p-Value aOR 95% CI p-Value aOR 95% CI p-Value aOR 95% CI

Geographic and temporal factors

Region (Northeast) Southeast 2.37 1.573.56 3.88 1.4010.78 2.62 1.355.09
West 2.12 1.413.19 4.19 1.4112.42 2.81 1.445.47
<0.001 <0.001 <0.001
Northwest 1.78 1.152.78 5.25 1.8914.53 1.55 0.753.20
Central 1.45 0.952.22 15.54 6.0140.23 3.46 1.756.87

Season (Winter) Autumn 1.48 1.141.91

Spring 0.020 1.24 0.971.58 NS NS
Summer 1.06 0.811.40

Month (July) January 1.65 0.813.37

February 1.09 0.512.36
March 1.78 0.873.62
April 1.86 0.893.90
May 1.26 0.562.79
June NS NS 0.020 1.26 0.562.83
August 1.36 0.613.01
September 2.66 1.305.47
October 2.62 1.285.39
November 1.86 0.844.13
December 3.25 1.536.91

Contact lens and patient factors

CL material (hydrogel)
SiHy <0.001 1.41 1.181.78 NS NS
Years of CL wear (<1 year of wear) >1 year <0.001 2.18 1.423.34 NS <0.001 2.78 1.345.75
CL replacement (daily) >Daily <0.001 1.68 1.022.78 NS NS
Overnight wear (No) Yes NS <0.001 0.15 0.050.41 <0.001 1.70 1.232.34
Lens care system (MPS) Other NS NS <0.001 0.54 0.350.83
Patient age N/A <0.001 Nonlinear <0.001 Nonlinear <0.001 Nonlinear

[23,24]. The CLAY study was not specically designed to study aller-
gic events and thus was not adequately powered to detect seasonal
variations across all regions; however, this analysis did demon-
strate a large and signicant risk of allergic events in the Central
region. Temporal and regional variations in serious and signicant
adverse events have also been reported in both contact lens wear-
ers and non-contact lens wearers [3,11,22,2530]. As both contact
lens materials and prescribing trends, as well as rules governing
the management and treatment of serious and signicant adverse
events eye conditions can vary signicantly by country and over
time, direct comparisons with contemporary studies conducted in
the United States and Canada are shown in Table 3. The increase in
infectious and inammatory events in the Autumn and Winter are
in agreement with the ndings of Chalmers et al. [11]. This study
adds a wider breadth of geographic regions, spans over four years
of routine exam ndings, and includes a larger number of patients,
examining doctors, and events.
There are limitations to this study. All of the sites were located at
academic optometry clinics, which may increase the likelihood of
practitioners recommending an interruption in contact lens wear
compared to other practitioners. The data were collected at ve
unique geographic locations but a single site may never adequately
represent the diversity within a region due to urban/rural differ-
ences, or more local variations in climate. Further, the study did

Table 3
Contemporary (last 25 years) North American studies examining seasonal or regional variations in contact lens events.

Report Study overview Key ndings

Location(s) Design Type of events studied Sample

CLAY study See Fig. 1 Retrospective Serious and signicant, 3515 patients Allergic:
record review Allergic, Other CL 522 events Highest in Central
20052009 interruptions Age 833 Serious and Signicant:
Highest in Autumn and Winter
Most regions equal except lower in
Northeast
All CL interruptions:
Highest in Autumn and South
Chalmers et al. [11] West: CA Retrospective Infectious 1276 patients Allergic:
Central: IN record review Inammatory 306 events Highest in Spring and Summer
Southeast: GA 20052006 Allergic Age 8 to >61 Inammatory:
Highest in Autumn
Infectious:
Highest in Winter
Regions not analyzed
Begley et al. [12] Central: IN Retrospective Allergic 68 patients Allergic:
record review (GPC only) 78 events Two peaks: Spring and late Summer/early
19871988 Age not reported Autumn
Only one region
 K. Richdale et al. / Contact Lens & Anterior Eye 36 (2013) 253258
Fig. 4. Events by season (top: all events, middle: allergic events, bottom: serious
and signicant adverse events).
Fig. 5. Serious and signicant adverse events by month.
257
not include representative sites from all US and Canadian regions.
One could argue that the practice patterns in Canada differ from
the United States, but our Northeast location, at the University of
Waterloo, has full prescribing privileges and has a scope of practice
similar to the US sites in this study and is climactically similar to
the US Northeast. The academic clinic sites could be biased to both
the type of patients examined and the diagnosis and treatment of
contact lens complications; however, the diversity of contact lens
materials and lens care products prescribed, and the volume of doc-
tors and patients included in the retrospective analysis should limit
potential biases over that of a single center, academic or other-
wise. This was a secondary analysis of an existing data set collected
from a retrospective record review. All contact lens interrupting
events that were culled from the records were included in this
analysis and, due to the limited numbers of cases for categories such
as lid events or mechanical events, only allergic and serious
and signicant events were analyzed as separate categories. Like-
wise, not all potential risk factors associated with these contact
lens complications could be ascertained from the available data
including specic local recordings of temperature and humidity.
Future, prospective studies could be designed to include multiple
types of practices (academic, private, and commercial practices of
both ophthalmologists and optometrists) across all North Ameri-
can regions, and with a specic protocol designed to assess anterior
segment ndings, culture of infectious or inammatory events, and
to evaluate local temperature and relative humidity variations as
described by Stapleton and colleagues [26].
Despite these limitations, and even after controlling for other
risk factors for contact lens wear, seasonal and regional factors were
signicantly associated with interruptions to safe and healthy soft
contact lens wear. Further, the adjusted odds ratios for regional and
temporal factors are of the same order as other well-established risk
factors such as extended wear, contact lens replacement schedule
and patient age. While the clinical adage that red eyes happen on
Friday at 5 pm was not supported by the data, these data provide
objective evidence for the clinical wisdom that location and time
of year are signicant inuences on successful contact lens wear.
With the expected rise in soft contact lens wear, clinicians may use
this knowledge to educate their patients and prepare their prac-
tice. Prior to a local rise in allergens, doctors, especially those in
the Central, may choose to re-t patients in daily disposable lenses
or preemptively prescribe or recommend anti-allergy medications
[31]. Before patients head back indoors for the Autumn and Win-
ter season, doctors can remind patients of the importance of hand
washing before applying or removing lenses and not rubbing or
touching the eyes throughout the day since both behaviors may be
vectors for inammatory and infectious events. Understanding all
of the associated risk factors for interruptions to contact lens wear
will ultimately help to promote continued safe and healthy lens
wear across all ages.
Acknowledgements
This study was supported by unrestricted grants from Alcon
Laboratories (Fort Worth, TX). The CLAY group has also received
logistical support from the American Academy of Optometry
Research Committee and the American Optometric Association
Council on Research. Portions of this work were presented at the
2010 meeting of the British Contact Lens Association (Birmingham,
UK).
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